August 20, 2020
By David Butcher, Staff Writer, MasterControl
When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.
August 19, 2020
By James Jardine, Staff Writer, MasterControl
A game-changing software solution that allows manufacturers to digitally connect and gain control of their data and documentation is now available globally and in 10 different languges. Learn how companies around the world are bridging the gap between operational excellence and smart manufacturing.
August 14, 2020
By Dale Thompson, Staff Writer, MasterControl
Contract manufacturing and packaging organizations adopted MasterControl’s Manufacturing Excellence™ and saw significant results including increased production capacity, transparency for customer audits, and faster time to market. Read more about our customers seeing improvements in metrics that matter.
August 13, 2020
By Mike Rigert, Staff Writer, MasterControl
Gathering momentum and power like a monster wave, Australia's life sciences sector is increasingly becoming a beacon for pharmaceutical and medical device manufacturers seeking regulatory approval for their products.
August 13, 2020
By Sarah Beale, Staff Writer, MasterControl
A platform approach is the ideal way to handle software solutions across an organization. However, no software provider has every type of software that a company might need. That’s why integration platform as a service (iPaaS) is so vital. It bridges the gap between solutions and gives you better control over your data.
August 11, 2020
By James Jardine, Staff Writer, MasterControl
The reluctance to abandon conventional paper-based quality management systems (QMS) has long typified the life sciences industry’s approach to quality. Familiar yet inefficient quality models are shortsighted, however.
August 7, 2020
By David Jensen, Staff Writer, MasterControl
Noticing an increase in violations of current good manufacturing practices (CGMP) regarding data integrity, the U.S. Food and Drug Administration (FDA) drafted a question-and-answer-based guidance to address some of the frequently asked questions and to clarify the role of data integrity in regulated product manufacturing.
August 6, 2020
By Dale Thompson, Staff Writer, MasterControl
Automation and digitization are rapidly becoming the norm for life sciences companies. While some people are concerned new technologies will replace workers, Mike Ferletic, President and CEO of Enterey, believes the opposite.
August 4, 2020
By Debby Newslow President/Owner/Consultant/Auditor/Trainer/Speaker/Author at D L Newslow & Associates, and Sarah Beale, Staff Writer, MasterControl
Companies that were prepared with good quality management have fared better during the pandemic. ISO 9001 in particular has proved inadvertently helpful in adapting to disruption. To see how ISO connects to COVID-19, we spoke to Debby Newslow of D.L. Newslow & Associates.
July 30, 2020
By James Jardine, Staff Writer, MasterControl
Whether you like it or not, you should brace yourself for Industry 5.0. The term refers to people working alongside robots and smart machines. If that definition brought to mind the image of Will Smith battling evil robots in the movie “I, Robot,” here are a few things you need to know about Industry 5.0.
July 28, 2020
By David Butcher, Staff Writer, MasterControl
The pandemic has highlighted the need for a faster, more flexible and scalable manufacturing environment that balances speed with compliance. While paper-based processes can slow production down or jeopardize quality, paperless production processes can streamline operations, reduce errors and readily leverage data critical to ensuring quality. A configurable, purpose-built electronic device history record (eDHR) application can be fast to implement and deliver quantifiable benefits.
July 27, 2020
By David Butcher, Staff Writer, MasterControl
A digital gap remains between quality assurance and manufacturing operations, as people on the production line still rely on paper-based production records and spreadsheets. This gap has left manufacturers susceptible to data entry errors, long good quality review times, shipment delays and other paper-based challenges. A paperless approach can deliver measurable results that have a notable impact on manufacturing operations, product quality and the bottom line.
July 27, 2020
By Sarah Beale, Staff Writer, MasterControl
How many times have you done something and immediately wished you could undo it? Or how many times have you wished you knew the outcome of something beforehand? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA).
July 24, 2020
By David Butcher, Staff Writer, MasterControl
The global COVID-19 pandemic has forced many manufacturers to re-examine how they manage their supply chains. Amid large-scale shocks to supply and demand, manufacturers and their supplier partners must balance speed with quality, without putting their own employees at risk or adding significant costs. Now is the time to. Leveraging digital supplier management tools can help manufacturers streamline supplier processes like audits and inspections without the on-site threat to employees and vendors and unnecessary travel costs.
July 17, 2020
By Jason Orloff, Statistical & Engineering Consultant, Pharmstat
The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).
July 17, 2020
By Belinda Dowsett, Quality Assurance Manager and Consultant, and Brandwood CKC
So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.
July 16, 2020
by Sarah Beale, Staff Writer, MasterControl
MasterControl Product Management Director Sue Marchant sat down with GxP Lifeline to talk about our platform approach, why that’s important and how it can eventually lead to artificial intelligence (AI) applications for our customers. She also gave us a sneak peek at what to expect in the next generation of MasterControl products.
July 15, 2020
By David Butcher, Staff Writer, MasterControl
Nelson Laboratories, a global provider of microbiological and analytical laboratory testing, is one of the many companies making an impact in the protective barriers area during the pandemic. The Salt Lake City-based company is heavily involved in testing the efficacy of facemasks and respirators. In a recent interview, Nelson Labs President Jeffrey R. Nelson spoke on what it has taken to achieve 24/7 coverage while maintaining quality and protecting employee health.
